Prognostic prediction marker for identifying subjects for postoperative adjuvant therapy for cervical cancer
By measuring AMIGO2 expression levels to determine whether patients with cervical cancer are suitable for adjuvant treatment, the controversial issue of treatment choices in the medium-risk group was solved, and personalized treatment plans were helped to reduce side effects and losses.
Patent Information
- Application Number
- JP2023179413
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-10-18
- Publication Date
- 2025-05-01
AI Technical Summary
The prior art is difficult to accurately determine whether adjuvant treatment is needed for patients with cervical cancer, especially in the medium-risk group, resulting in controversy in the treatment choices and affecting the quality of life of patients.
By measuring AMIGO2 expression levels in the patient tissue, it is determined whether it is above the reference value, and it is determined whether it is suitable for adjuvant therapy.
Patients with AMIGO2 expression levels above the reference value are determined to be suitable for adjuvant treatment, while those below the reference value are not suitable, helping to develop personalized treatment plans to reduce unnecessary side effects and economic and social losses.
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Abstract
Description
[Technical field]
[0001] The present disclosure relates to a method for collecting data for determining whether a subject is suitable for adjuvant therapy for cervical cancer, and a method for determining whether a subject is suitable for adjuvant therapy for cervical cancer. [Background technology]
[0002] Cervical cancer is the fourth most common malignancy in women worldwide. In 2020, approximately 600,000 new cases will be diagnosed and approximately 340,000 deaths will occur due to cervical cancer. Approximately 90% of cases and deaths occur in low- and middle-income countries; although mortality rates are low in high-income countries due to widespread use of human papillomavirus vaccines, regular screening, and appropriate treatment, the prognosis for patients with advanced or recurrent cervical cancer remains unacceptable.
[0003] The standard treatment for cervical cancer is surgery or radiation therapy, and the choice is based on the clinical stage and treatment plan. Patients who undergo surgery are required to undergo adjuvant therapy according to their recurrence risk classification. Adjuvant therapy, which is performed after surgery to prevent recurrence, is accompanied by significant side effects. Many cervical cancer patients are in their 30s and 40s, in the prime of their working lives, and the choice of whether or not to undergo adjuvant therapy (especially chemotherapy and / or radiation therapy), which has strong side effects and is likely to significantly interfere with daily life such as work and childcare, can be an important choice that greatly affects quality of life.
[0004] Risk factors for recurrence of cervical cancer include regional lymph node metastasis, parametrial invasion, stromal invasion, lymphovascular space invasion (LVSI), and tumor size. Recurrence risk classification (high risk, medium risk, low risk) is determined based on these risk factors. Medium risk is defined based on the Sedlis criteria, which state that 1) more than one-third of the tumor is stromal invasion, 2) vascular invasion, and 3) the diameter of the cervical tumor is 4 cm or more (Non-Patent Document 1), and this definition is widely used in Japan. However, other studies have also shown the need to consider the histological type of the tumor and the proximity or positivity of the surgical margin (Non-Patent Documents 2 to 5).
[0005] In general, low-risk patients do not require postoperative adjuvant therapy. However, postoperative treatment is recommended as standard for high-risk patients. In addition, the guidelines of the US National Comprehensive Cancer Network recommend postoperative adjuvant therapy for medium-risk patients as well (Non-Patent Document 6). However, treatment for the medium-risk group is not standardized and varies depending on the medical facility. Whether all medium-risk cases should receive postoperative adjuvant therapy is under discussion and remains an unsolved issue. In order to make the appropriate choice, postoperative adjuvant therapy should be administered to subjects who are likely to truly require postoperative adjuvant therapy to prolong survival, and postoperative adjuvant therapy, which is accompanied by strong side effects and interferes with daily life, should be avoided for subjects who are likely not to require postoperative adjuvant therapy. In order to make the appropriate choice, a suitable marker that can more accurately predict the risk of recurrence of cervical cancer is required.
[0006] Needless to say, the risk of recurrent cervical cancer as a disease cannot be ignored. However, taking into account the severity of the side effects of adjuvant therapy, the economic losses associated with unnecessary treatment, and the social losses associated with the interruption of the activities of women in the prime of their working lives, the significance of developing an independent marker that will help identify patients who should be candidates for adjuvant therapy is extremely great.
[0007] Recently, the present inventors' group reported that the expression of a protein called amphoterin-induced gene and open reading frame 2 / adhesion molecule with IgG domain 2 (AMIGO2) in colon cancer tissue samples correlated with liver metastasis, but not with lung metastasis or peritoneal metastasis (Non-Patent Document 7). The present inventors' group further reported that the expression of AMIGO2 in gastric cancer tissue samples was a prognostic factor for overall survival, disease-free survival, and liver metastasis, but was not a significant prognostic factor for lung metastasis or lymph node metastasis (Non-Patent Document 8). However, the association between AMIGO2 levels and cervical cancer remained unclear. [Prior art documents] [Non-patent literature]
[0008] [Non-Patent Document 1] Sedlis et al., Gynecol Oncol 73: 177-183, 1999. [Non-Patent Document 2] Ryu et al., Br J Cancer 110: 278-285, 2014. [Non-Patent Document 3] Noh et al., Gynecol Oncol 132: 618-623, 2014. [Non-Patent Document 4] Diaz et al., Gynecol Oncol 132: 76-80, 2014. [Non-Patent Document 5] Estape et al., Gynecol Oncol 68: 229-232, 1998. [Non-Patent Document 6] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Cervical Cancer. Version 1. National Comprehensive Cancer Network, 2023 [Non-Patent Document 7] Tanio et al., Oncol Lett 21: 278, 2021. [Non-Patent Document 8] Goto et al., BMC Cancer 22: 280, 2022. Summary of the Invention [Problem to be solved by the invention]
[0009] The present disclosure has been made to solve the above-mentioned problems, and aims to provide a method for collecting data for determining whether or not a subject is suitable for postoperative adjuvant therapy for cervical cancer. In another aspect, the present disclosure aims to provide a method for determining whether or not a subject is suitable for postoperative adjuvant therapy for cervical cancer. [Means for solving the problem]
[0010] In one embodiment, the present disclosure provides a method for collecting data to determine whether a subject is suitable for adjuvant therapy for cervical cancer, the method comprising measuring AMIGO2 expression levels in a tissue of the subject.
[0011] In one aspect, the present disclosure provides a method for determining whether a subject is suitable for adjuvant therapy for cervical cancer, the method comprising determining that the subject is suitable for adjuvant therapy for cervical cancer if the subject's AMIGO2 level is higher than a reference value, and determining that the subject is not suitable for adjuvant therapy for cervical cancer if the subject's AMIGO2 level is equal to or lower than the reference value. [Brief description of the drawings]
[0012] [Figure 1] Figure 1 shows immunohistochemical staining of AMIGO2 in cervical cancer tissues. Figure 1A and B show typical cervical squamous cell carcinomas, while Figure 1C and D show typical cervical adenocarcinomas. [Diagram 2]Figure 2 shows disease-free survival curves and the number of people at risk for each of the AMIGO2-Low (black) and AMIGO2-High (gray) expression groups in the entire study. The horizontal axis of the graph indicates time in months. P values were calculated using the Kaplan-Meyer method. [Diagram 3] Figure 3 shows disease-free survival curves and the number of patients at risk for each group in the AMIGO2 low expression group (black) and the AMIGO2 high expression group (gray) in subjects classified as at intermediate risk of recurrence according to the Sedlis criteria. The horizontal axis of the graph indicates time in months. P values were calculated using the Kaplan-Meyer method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] <Method of collecting data to determine suitability for postoperative adjuvant therapy for cervical cancer>
[0014] One aspect of the present disclosure provides a method for collecting data for determining whether or not a patient is suitable for adjuvant therapy for cervical cancer, comprising measuring the AMIGO2 expression level in a target tissue.There has been a strong need for determining whether a patient with cervical cancer is suitable for adjuvant therapy, but the technical field lacks a basic understanding of whether there is a molecular marker that is effective for such a determination, and if there is, what should be looked at.The embodiment of the present disclosure provides for the first time a specific preparation means and execution means for making such a determination.
[0015] The subject in the data collection method of the embodiment includes cervical cancer patients (particularly human patients) as well as cervical cancer model organisms. In the embodiment, the subject can be a mammal, including a human, mouse, or rat. In the embodiment, the subject is a female individual (woman) of a mammal.
[0016] In the data collection method of the embodiment, the subject is an animal suffering from cervical cancer. In the embodiment, the subject may be a subject who has undergone surgery for cervical cancer, or a subject who is scheduled or likely to undergo surgery for cervical cancer, and is preferably a human cervical cancer patient who has undergone surgery for cervical cancer, or is scheduled or likely to undergo surgery for cervical cancer. The term "surgery" as used herein means a surgical procedure for removing cervical cancer, and may be, for example, a total hysterectomy or a trachelectomy. As will be understood by those skilled in the art, a patient who undergoes such surgery may be, for example, a patient with cervical cancer at stages IB to II according to the classification according to FIGO (International Federation of Gynecology and Obstetrics) 2018. A patient with cervical cancer at stages IB to II may partially overlap with a medium-risk patient, which will be described later.
[0017] Risk factors for cervical cancer recurrence include regional lymph node metastasis, parametrial invasion, stromal invasion, lymphovascular space invasion (LVSI), and tumor size. Recurrence risk classification (high risk, medium risk, low risk) is determined based on these risk factors. In this disclosure, the definition of medium risk is based on the Sedlis criteria, which are 1) more than one-third stromal invasion, 2) vascular invasion, and 3) cervical tumor diameter 4 cm or more. Those skilled in the art will understand that the Sedlis criteria are described in Non-Patent Document 1.
[0018] In the data collection method of the embodiment, the subject is preferably a patient classified as being at high or medium risk of recurrence according to the Sedlis criteria, and more preferably a patient classified as being at medium risk of recurrence according to the Sedlis criteria.
[0019] The cervical cancer in the data collection method of the embodiment is a cancer occurring in the cervix. The cancer in the embodiment is not limited to a tissue type including whether or not it is a recurrent cancer itself, and squamous cell carcinoma and adenocarcinoma.
[0020] As understood by those skilled in the art, the adjuvant therapy in this specification means a postoperative treatment performed after cervical cancer surgery for the purpose of preventing recurrence. In the "2017 Edition of Cervical Cancer Treatment Guidelines" by the Japanese Society of Gynecologic Oncology, it is defined as "Postoperative adjuvant therapy is a postoperative treatment performed for the purpose of preventing recurrence in cases where the planned surgical procedure has been completed and the patient has a risk factor for postoperative recurrence based on the histopathological findings of the surgically excised specimen." In this specification, the adjuvant therapy includes the treatment methods included in the above definition. However, the definition of the above guideline is written on the premise that a step of histopathological examination is performed on the specimen excised by the completed planned surgical procedure itself to determine the postoperative recurrence risk, but the embodiment of the present disclosure is not limited to that step, and for example, the postoperative recurrence risk can be determined by collecting data by measuring the AMIGO2 expression level in a cancer tissue biopsy specimen before the planned surgical procedure is completed.
[0021] In an embodiment, the adjuvant therapy can be radiation therapy, concurrent chemoradiotherapy (CCRT), or chemotherapy. Chemotherapy, radiation therapy, or a combination thereof suitable for adjuvant therapy of cervical cancer are known to those skilled in the art, and a representative chemotherapy involves administration of cisplatin.
[0022] Following the collection of data using the data collection method of the embodiment, the determination of whether or not a subject is suitable for postoperative adjuvant therapy for cervical cancer can be made using the determination method described below in <Method for determining whether or not a subject is suitable for postoperative adjuvant therapy for cervical cancer>.
[0023] The data collection method of the embodiment includes a step of measuring the AMIGO2 expression level in the subject's tissue. The measurement of the AMIGO2 expression level in the embodiment can be performed by a method known to those skilled in the art, including immunohistochemistry, quantitative PCR, and Western blotting, but is preferably performed by immunohistochemistry for the AMIGO2 protein. Immunohistochemistry includes enzyme antibody techniques, fluorescent antibody techniques, and the like. The proportion of AMIGO2-positive cells in the immunohistochemistry specimen can be used as an indicator of the AMIGO2 expression level. The immunohistochemistry can be performed using an anti-AMIGO2 antibody, and the antibody used in such immunohistochemistry can be obtained by a method known to those skilled in the art.
[0024] In the present disclosure, AMIGO2 refers to the gene product of a gene known as amphoterin-induced gene and open reading frame 2. AMIGO2 is also known as adhesion molecule with Ig like domain 2, and the NCBI Gene IDs of the AMIGO2 genes of human, mouse, and rat are 347902, 105827, and 300186, respectively. The gene product may be a protein or an mRNA. The gene product is preferably a protein. It is understood by those skilled in the art that the signal intensity in immunohistochemical analysis may be correlated with the protein level and the mRNA level.
[0025] The method according to the present disclosure can be carried out in vitro, i.e., tissues separated from the body of a subject can be used. The subject tissue in the step of measuring the AMIGO2 expression level of the embodiment can be tumor tissues taken from a subject, particularly cervical cancer tumor tissues. The tumor tissue is preferably, but not limited to, tissues contained in the surgically resected specimen of cervical cancer itself. For example, the tumor tissue can be a surgically resected specimen or biopsy tissue derived from a primary or metastatic lesion.
[0026] <Method for determining suitability for postoperative adjuvant therapy for cervical cancer>
[0027] One aspect of the present disclosure provides a method for determining whether a subject is suitable for adjuvant therapy for cervical cancer, in which the subject is determined to be suitable for adjuvant therapy for cervical cancer when the AMIGO2 expression level in the tissue of the subject is higher than a reference value, and the subject is determined to be unsuitable for adjuvant therapy for cervical cancer when the AMIGO2 expression level in the tissue of the subject is equal to or lower than the reference value. The elements of this method (subject, measurement of AMIGO2 expression level, medium risk group of recurrence, etc.) can be applied to the explanation provided in relation to the embodiment of the above <Method for collecting data for determining whether a subject is suitable for adjuvant therapy for cervical cancer>.
[0028] In the embodiment of the method of determination, the determination of whether or not a subject is suitable for adjuvant therapy for cervical cancer can be performed by determining whether the subject belongs to a group with a long expected disease-free survival time or a group with a short expected disease-free survival time. If the subject belongs to the former group, the subject is determined to be unsuitable for adjuvant therapy for cervical cancer, and if the subject belongs to the latter group, the subject is determined to be suitable for adjuvant therapy for cervical cancer. The determination of which group the subject belongs to can be performed using a reference value related to the expression level of AMIGO2.
[0029] In the embodiment of the determination method, the reference value means a reference value of AMIGO2 expression level for determining that if the subject's AMIGO2 level is higher than the reference value, the subject belongs to a group with a short expected disease-free survival period and is therefore suitable for adjuvant therapy for cervical cancer, and that if the AMIGO2 level is lower than the reference value, the subject belongs to a group with a long expected disease-free survival period and is therefore not suitable for adjuvant therapy for cervical cancer.
[0030] It is understood by those skilled in the art that the specific reference value may vary depending on the type of measurement assay and the specificity and sensitivity of the determination required in each application, and can be appropriately selected. Based on the AMIGO2 levels of samples from recurrent and non-recurrent groups not subjected to postoperative adjuvant therapy obtained in individual medical institutions, or by reference to the present disclosure, a specific reference value can be provided by a medically appropriate method known by those skilled in the art.
[0031] In the determination method of the embodiment, the reference value can be the proportion of AMIGO2-positive cancer cells by immunohistochemistry. As described in Non-Patent Document 8, a person skilled in the art can clearly distinguish AMIGO2-positive cancer cells from the surrounding AMIGO2-negative cells. For example, the reference value n can be a value within the range of 50 to 90%, or 60 to 80%, or 70%, and if the proportion of AMIGO2-positive cancer cells by immunohistochemistry is greater than n, the patient can be determined to be suitable for postoperative adjuvant therapy.
[0032] The method of the embodiment may further include measuring the expression level of AMIGO2. The expression level of AMIGO2 may be measured by the method described in the above section "Method of collecting data for determining whether or not a patient is suitable for adjuvant therapy for cervical cancer."
[0033] In the method of the embodiment, the subject is preferably classified into a high or medium risk group of recurrence according to the Sedlis criteria, more preferably into a medium risk group of recurrence according to the Sedlis criteria. The subject may be a patient with cervical cancer of stage IB to II according to the FIGO 2018 classification, and such a patient group may partially overlap with the above-mentioned medium risk patient group.
[0034] <Kit> In one aspect, the present disclosure includes a kit for carrying out the above-mentioned method for collecting data for determining whether or not a subject is suitable for adjuvant therapy for cervical cancer, or the method for determining whether or not a subject is suitable for adjuvant therapy for cervical cancer. The kit includes an anti-AMIGO2 antibody, and further includes instructions including instructions for performing immunohistochemistry of a subject's cervical cancer tissue using the anti-AMIGO2 antibody to measure the AMIGO2-positive cell rate. The instructions may further include instructions for comparing the measured AMIGO2-positive cell rate with a reference value. The instructions may further include instructions for determining that the subject is suitable for adjuvant therapy for cervical cancer if the measured AMIGO2-positive cell rate is higher than the reference value, and determining that the subject is not suitable for adjuvant therapy for cervical cancer if the measured AMIGO2-positive cell rate is equal to or lower than the reference value. EXAMPLES
[0035] <Introduction> Using immunohistochemical analysis of cervical tumor samples and clinical evaluation of patients, we aimed to determine whether AMIGO2 could predict cervical cancer recurrence and whether AMIGO2 was associated with prognostic factors of cervical cancer.
[0036] Materials and Methods Patient samples This study was approved by the Institutional Review Board of Tottori University Hospital. Patients who underwent radical hysterectomy or radical trachelectomy for preoperative diagnosis of early cervical cancer (clinical T1N0M0 or T2N0M0) at Tottori University between 2005 and 2016 were included. All patients obtained opt-out consent according to the institution's guidelines. Immunohistochemical analysis was performed on 101 specimens. Recurrence risk was classified as low, medium, or high based on postoperative pathological diagnosis. High risk (24 specimens) was associated with positive regional lymph nodes and parametrial invasion. Medium risk (29 specimens) was determined according to the Sedlis criteria by meeting the following criteria: "stromal invasion in more than one third," "vascular invasion," or "cervical tumor diameter ≥ 4 cm." Low risk (48 specimens) included pathologies excluded from high and medium risk. High-risk patients in principle received standard clinical treatment (adjuvant CCRT; pelvic radiotherapy totaling 45-50 Gy / 5-6 weeks, chemotherapy with cisplatin 40 mg / m2 / week). Low-risk and intermediate-risk patients (none of whom received adjuvant CCRT) were closely monitored. Clinical characteristics, recurrence, recurrence type, disease-free survival (DFS), and overall survival (OS) were retrospectively investigated based on clinical records. Recurrence types were divided into distant metastasis and local recurrence, including vaginal or pelvic recurrence.
[0037] Immunohistochemical staining Cervical cancer samples were fixed in formalin and embedded in paraffin. Serial sections were cut at 4 μm, deparaffinized in xylene for 15 min, and rehydrated in a graded alcohol series for 15 min. Sections were autoclaved in 10 mM citrate buffer (pH 6.0) in a microwave for 10 min, and then incubated in 3% hydrogen peroxide (Nichirei Biosciences, Inc., 426042, Tokyo, Japan) for 20 min to block endogenous peroxidase and prevent nonspecific antigen binding. Slides were then incubated with rat anti-AMIGO2 antibody (rTNK1Bo12a, 1:1,000 dilution) at 4°C overnight. Sections were then incubated with goat polyclonal anti-rat IgG horseradish peroxidase-conjugated antibody (Abcam, ab98425, Cambridge, UK, 1:300 dilution) for 20 min at 20°C. Positive reactions were visualized using a peroxidase substrate kit (Vector Laboratories, SK-4105, Burlingame, CA, USA), and sections were counterstained with hematoxylin. Using a microscope (Leica, DM500, Wetzlar, Germany), cancer cells with a positive rate of >70% and <70% were defined as high and low AMIGO2 expression groups, respectively.
[0038] statistical analysis Patient survival distributions were determined using the Kaplan-Meier method and the log-rank test. Categorical variables were analyzed using Fisher's exact test. Univariate and multivariate analyses were performed using the Cox proportional hazards model. Statistical significance was considered to be P<0.05. Statistical analyses were performed using EZR software version 1.54.
[0039] <Result> Immunohistochemical detection of AMIGO2 expression and clinicopathological factors in cervical cancer To confirm AMIGO2 expression in cervical cancer, we performed immunohistochemical analysis using an AMIGO2-specific antibody. Cervical cancers were histologically classified into squamous cell carcinoma (SCC) (Fig. 1A and B) and adenocarcinoma (non-SCC), including adenosquamous carcinoma (C and D), and AMIGO2 expression was analyzed. No association was found between histological type and AMIGO2 expression. However, in all histological types, AMIGO2 expression was high in cancer cells and low in the surrounding stroma. AMIGO2 protein was localized in both the nucleus and cytoplasm (Fig. 1A and C). Based on a cutoff value of 70% for the rate of AMIGO2-positive cells in cancer cells, the cancers were classified into an AMIGO2-high group (Fig. 1A and C) and an AMIGO2-low group (Fig. 1B and D), regardless of histological type. Of the 101 specimens, 40 specimens were classified into the AMIGO2-high group and 61 specimens into the AMIGO2-low group. In Figure 1, the entire tissue is stained blue-purple with hematoxylin, whereas the AMIGO2-positive cancer cells are clearly stained with a brown dye.
[0040] AMIGO2 expression as a predictor of cervical cancer recurrence Kaplan Meier survival analysis and log-rank test were performed to investigate the relationship between AMIGO2 expression and prognosis in cervical cancer. Patients in the AMIGO2 high group had a lower 5-year disease-free survival (DFS) rate than those in the AMIGO2 low group (59% [95% confidence interval (CI) 42-73%] vs. 95% [95% CI 85-98%] (P < 0.001) (Figure 2).
[0041] Next, we investigated independent risk factors for DFS, focusing only on the intermediate-risk group. The factors examined were age, histology, tumor size, stromal invasion, LVSI, and AMIGO2 in univariate analysis, and tumor size, stromal invasion, LVSI, and AMIGO2 in multivariate analysis. Of the 29 specimens in the intermediate-risk group, 17 specimens were AMIGO2 low and 12 specimens were AMIGO2 high. In the univariate analysis of DFS, only AMIGO2 expression was a significant prognostic factor. In the multivariate analysis, AMIGO2 expression was the only independent prognostic factor for DFS (Table 1).
[0042] [Table 1]
[0043] Kaplan-Meier curves for DFS were then generated for the intermediate-risk category. As shown in Figure 3, even in the intermediate-risk group alone, AMIGO2 expression levels were able to distinguish with remarkable clarity between patients with poor 5-year DFS and a high likelihood of needing adjuvant therapy (AMIGO2-High patients) and those with good 5-year DFS and therefore less likely to benefit from adjuvant therapy (AMIGO2-Low patients).
[0044] <Conclusion> The results illustrated in this study clearly demonstrated that AMIGO2 expression is a marker for the suitability of adjuvant therapy in intermediate-risk patients, and therefore measuring AMIGO2 expression levels can help determine the appropriate treatment strategy for intermediate-risk patients.
[0045] Embodiments of the present disclosure may include the following. (Section 1) A method for collecting data to determine whether a subject is suitable for adjuvant therapy for cervical cancer, the method comprising a step of measuring the AMIGO2 expression level in the subject's tissue. (Section 2) The method according to item 1, wherein the subject is a patient classified as being at medium risk of recurrence according to the Sedlis criteria. (Section 3) The method according to item 1 or 2, wherein the subject is a patient with stage IB to II cervical cancer according to the FIGO 2018 classification. (Section 4) A method for determining whether a subject is suitable for adjuvant therapy for cervical cancer, comprising determining that the subject is suitable for adjuvant therapy for cervical cancer if the AMIGO2 expression level in the subject's tissue is higher than a reference value, and determining that the subject is not suitable for adjuvant therapy for cervical cancer if the AMIGO2 expression level in the subject's tissue is lower than the reference value. (Section 5) The method of claim 4, further comprising measuring the AMIGO2 expression level of the subject. (Section 6) The method according to item 4 or 5, wherein the subject is classified into the medium risk group for recurrence according to the Sedlis criteria. (Section 7) The method according to any one of items 4 to 6, wherein the subject is a patient with cervical cancer classified according to FIGO 2018 at stage IB to II. (Section 8) A kit for carrying out the method described in any one of claims 1 to 7, comprising an anti-AMIGO2 antibody and instructions containing instructions for performing immunohistochemistry of a subject's cervical cancer tissue using the anti-AMIGO2 antibody to measure the AMIGO2-positive cell rate.
Claims
1. A method for collecting data for determining whether a subject is suitable for adjuvant therapy for cervical cancer, comprising: Measuring the AMIGO2 expression level in the subject's tissue. The method includes:
2. The method according to claim 1, wherein the subject is a patient classified as at medium risk of recurrence according to the Sedlis criteria.
3. The method of claim 1, wherein the subject is a patient with stage IB to II cervical cancer according to FIGO 2018 classification.
4. A method for determining whether a subject is suitable for adjuvant therapy for cervical cancer, comprising: If the AMIGO2 expression level in the tissue of the subject is higher than the reference value, the subject is determined to be suitable for postoperative adjuvant therapy of cervical cancer; If the AMIGO2 expression level in the tissue of the subject is equal to or lower than the reference value, the subject is determined to be unsuitable for postoperative adjuvant therapy for cervical cancer. method.
5. The method of claim 4, further comprising measuring the AMIGO2 expression level of the subject.
6. The method according to claim 4 or 5, wherein the subject is classified as being at medium risk of recurrence according to the Sedlis criteria.
7. The method according to claim 4 or 5, wherein the subject is a patient with cervical cancer classified as stage IB to II according to FIGO 2018.
8. Anti-AMIGO2 antibody, An instruction manual including an explanation on immunostaining a subject's cervical cancer tissue using the anti-AMIGO2 antibody to measure the AMIGO2 positive cell rate. A kit for carrying out the method according to claim 1 or 5, comprising: